Warfarin fared no better than aspirin at reducing the combined risk of brain hemorrhage, stroke, or death for heart-failure patients in normal rhythm, according to the results of a study published in the New England Journal of Medicine.
The study, called Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF), was designed to determine whether warfarin had an advantage over aspirin as a treatment for patients with a reduced left ventricular ejection fraction (LVEF) who are in normal rhythm. Previous studies reported conflicting results.
The double-blind, multicenter clinical trial took place at 168 centers in 11 countries from October 2002 through January 2010. Shunichi Homma, MD, of Columbia University Medical Center in New York City, and colleagues randomly assigned 2,305 patients (mean age, 61 years) with severe LVEF (mean fraction of 25%) to receive warfarin or aspirin for a mean of 3.5 years.
The primary outcome was the time to the first event in a composite end point of ischemic stroke, intracerebral hemorrhage, or death from any cause.
The investigators found no significant difference between the 2 groups. For patients treated with warfarin, the rates of the primary outcome were 7.47 events per 100 patient-years, and for those treated with aspirin the rates were 7.93 per 100 patient-years (HR with warfarin=0.93; 95% CI, 0.79–1.10; P=.40).
The authors did note that warfarin appeared to offer an advantage over aspirin in the prevention ischemic stroke that seemed to increase over time, however the benefit was offset by an increase in the rate of major bleeding.
“Given the finding that warfarin did not provide an overall benefit and was associated with an increased risk of bleeding, there is no compelling reason to use warfarin rather than aspirin in patients with a reduced LVEF who are in sinus rhythm,” the researchers concluded.
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BY
AKSHAYA SRIKANTH
Pharm.D Resident
Hyderabad
INDIA
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